Standards for Pediatric Immunization Practices

Summary

Although 97%-98% of children in the United States are
vaccinated before or shortly after starting school, the proportion
of preschool children who have completed a full series for all
recommended vaccines is considerably lower. Although low
immunization coverage among preschoolers has been attributed to
difficulties in reaching certain groups, such as the urban poor and
racial and ethnic minorities, more recent evaluations suggest that
the health-care delivery system itself bears much of the
responsibility. To eliminate barriers and obstacles (e.g.,
appointment-only systems and unnecessary prevaccination physical
examinations) that impede efficient vaccine delivery and to
encourage providers to take advantage of all health-care visits as
opportunities to provide vaccinations, the National Vaccine
Advisory Committee (NVAC) called for the development of standards
for immunization policies and practices. Eighteen standards were
developed in collaboration with a 35-member working group
representing 22 public and private agencies. These 18 standards
have since been recommended by the NVAC, approved by the U.S.
Public Health Service, and endorsed by the American Academy of
Pediatrics. The standards are presented and discussed in detail in
this report.

INTRODUCTION

The resurgence of measles in the United States during the
period 1989-1991 was associated with 55,622 reported cases (1,2),
11,251 hospitalizations, greater than 42,000 hospital days (CDC,
unpublished data), and 166 suspected deaths from measles (3). The
cause of the epidemic was failure to vaccinate children at the
recommended age of 12-15 months (4).

Although 97%-98% of children in the United States are
vaccinated before or shortly after starting school with four doses
of diphtheria and tetanus toxoids and pertussis vaccine (DTP),
three doses of oral poliovirus vaccine (OPV), and one dose of
measles-mumps-rubella (MMR) vaccine, series-complete immunization
levels among preschool-age children are considerably lower. Recent
surveys of children starting school in nine cities measured
immunization status as of the second birthday and documented that
only 52%-71% had been vaccinated against measles (5).
Series-complete immunization levels ranged from 10% to 42%. These
coverage levels are substantially lower than the Healthy People
2000 national goal of 90% coverage levels by the second birthday
(6).

Immunization of preschool-age children is intended to provide
early protection to this most vulnerable group, and approximately
80% of the routine childhood vaccines are currently recommended to
be administered by 15-18 months of age. In addition, the
recommended vaccine series has been expanded to include three or
four doses of Haemophilus influenzae b vaccine and three doses of
hepatitis B vaccine (7-10).

Low immunization coverage has been attributed to difficulties
in reaching certain groups in the population. These groups include
the urban poor and racial and ethnic minorities. However, recent
evaluations suggest that the health-care delivery system itself
bears much of the responsibility (11,12). Parents seeking
vaccination for their children face barriers and obstacles, such as
long waiting periods, appointment-only services, and prevaccination
physical examinations, that impede efficient vaccine delivery. In
addition, not all providers take advantage of all opportunities to
administer needed vaccines, because of failure either to screen the
immunization status of a child during a health-care visit or to
administer simultaneously all vaccines for which a child is
eligible. Inadequate or lacking third-party payment for
vaccinations further reduces coverage.

The measles epidemic signaled that the immunization delivery
system must be changed immediately if the nation's children are to
be fully protected. The system requires both enhancement of
outreach capacity and modifications of policies and practices to
remove the above-mentioned barriers and improve access. The
National Vaccine Advisory Committee (NVAC), therefore, made 13
recommendations to improve vaccine delivery in the United States
(4). Recognizing that both barriers to the receipt of vaccinations
and missed opportunities to vaccinate contribute to low coverage
levels, NVAC in one of its recommendations called for standards to
guide immunization practices.

The resulting Standards for Pediatric Immunization Practices
(see box on page 3) were developed by CDC in collaboration with a
35-member working group representing 22 public and private agencies
that had input from state and local health departments, physician
and nursing organizations, and public and private providers
involved in clinical care and in prevention health services. The
Standards represent the consensus of the NVAC and the working group
that address the most essential and desirable immunization policies
and practices for an immunization service. The Standards are
accompanied by a Guide to Contraindications and Precautions to
Immunization (Table 1), which reflects the current recommendations
of the Advisory Committee on Immunization Practices (ACIP), as well
as the Committee on Infectious Diseases of the American Academy of
Pediatrics (AAP) (7,8).

The Standards have been endorsed by several medical and public
health organizations. These organizations encourage adherence to
the Standards for Pediatric Immunization Practices as a key element
in our national strategy to administer vaccines more efficiently
and effectively to the nation's children.

THE STANDARDS

Ideally, immunizations should be administered as part of
comprehensive child health care. Overall improvement in our
primary-care delivery system requires intensive effort and will
take time. However, providing effective immunization programs
should not depend on changes in this system before vaccinations are
delivered more effectively to U.S. children.

Current health-care policies and practices in all settings
result in the failure to deliver vaccines on schedule to many
vulnerable preschool-age children. This failure is due primarily to
barriers that impede vaccine delivery and to missed opportunities
during clinic visits. Changes in policies and practices can
immediately improve coverage. The present system should be geared
to "user-friendly," family-centered, culturally sensitive, and
comprehensive primary health care that can provide rapid,
efficient, and consumer-oriented services to the users, i.e.,
children and their parents. The failure to do so is evidenced by
the recent resurgence of measles and measles-related childhood
mortality, which may be a precursor of other vaccine-preventable
disease outbreaks. The following Standards for Pediatric
Immunization Practices and the accompanying discussions address
these issues.

Standard 1.

Immunization services are readily available.
Discussion: Immunization services should be responsive to the
needs of patients. For example, in large urban areas, public
immunization clinic services should be available daily, 8 hours per
day. In smaller cities and rural areas, clinics may operate less
frequently. To be fully responsive, providers in many locations
should consider offering immunization services each working day as
well as during some off-hours (e.g., weekends, evenings, early
mornings, or lunch hours). Immunization services should be
considered for all days and at all hours that other child health
services at the same site are offered (e.g., the Special
Supplemental Food Program for Women, Infants, and Children {WIC}).
Private providers who offer primary care to infants and children
should always include immunization services as a routine part of
that care.

Ready availability of immunization services also requires that
the supply of vaccines be adequate at all times.

Standard 2.

There are no barriers or unnecessary prerequisites to the
receipt of vaccines.

Discussion: Appointment-only systems often act as barriers to
immunization in both public and private settings. Immunization
services should be available on a walk-in basis at all times for
both routine and new enrollee visits. Waiting time should be
minimized and generally should not exceed 30 minutes. Furthermore,
administration of needed vaccines should not be contingent on
enrollment in a well-baby program unless enrollment is immediately
available. Children coming only for vaccinations should be rapidly
and efficiently screened without requiring other comprehensive
health services. However, children who receive vaccinations in such
an "express lane" fashion and who do not have a primary-care
provider should be referred to one.

Physical examinations and temperature measurements before
vaccination should not be required if they delay or impede the
timely receipt of vaccinations (e.g., appointments for physical
examination in some facilities may take weeks to months to
schedule). A reliable decision to vaccinate can be based
exclusively on the information elicited from a parent or guardian
and on the provider's observations and judgment about the child's
wellness at the time of vaccination. At a minimum, children should
have prevaccination assessments, including a) observing the child's
general state of health, b) asking the parent or guardian if the
child is well, and c) questioning the parent or guardian about
potential contraindications (Table 1).

In public clinic settings, the administration of vaccines
should not depend on individual written orders or on a referral
from a primary-care provider. Rather, standing orders should be
developed and implemented.

Standard 3.

Immunization services are available free or for a minimal fee.
Discussion: In the public sector, vaccinations should be free
of charge. If fees must be collected, they should be kept to a
minimum. In the private sector, charges should include the cost of
the vaccine and a reasonable administration fee.

Affordable vaccinations will limit fragmentation of care and
help assure immunization of the greatest number of children. Public
and private providers who charge a fee to administer vaccines
obtained through a consolidated federal contract should prominently
display a state-approved sign indicating that no one will be denied
immunization services because of inability to pay the fee.

Discussion: Each encounter with a health-care provider,
including an emergency room visit or hospitalization, is an
opportunity to screen vaccination status and, if indicated,
administer needed vaccines. Before discharge from the hospital,
children should receive vaccinations for which they are eligible by
age or health status. The child's regular health-care provider
should be informed about the vaccinations administered.
Implementation of this standard minimizes the number of missed
opportunities to vaccinate.

In addition, children accompanying parents or siblings who are
seeking any service should also be screened and, when indicated,
should be administered needed vaccines. Providers in subspecialty
clinics (e.g., oncology) who care for children should pay
particular attention to the vaccination status of their patients
and vaccinate or refer them to immunization services or primary
health-care providers as appropriate.

Providers in other specialties should also note the
vaccination status of children and refer or vaccinate as
appropriate.

Standard 5.

Providers educate parents and guardians about immunization in
general terms.

Discussion: Providers should educate parents and guardians in
a culturally sensitive way, preferably in their own language, about
the importance of immunizations, the diseases they prevent, the
recommended vaccination schedules, the need to receive vaccinations
at recommended ages, and the importance of bringing their child's
immunization record to each visit. Parents should be encouraged to
take responsibility for ensuring that their child completes the
full series. Providers should answer all questions parents and
guardians may have and provide appropriate educational materials at
suitable reading levels in the parents' or guardians' own language.

Standard 6.

Providers question parents or guardians about contra-
indications and, before vaccinating a child, inform them in
specific terms about the risks and benefits of the vaccinations
their child is to receive.

Discussion: Minimal acceptable screening procedures for
precautions and contraindications include asking questions to
elicit a possible history of adverse events following prior
immunizations and determining any existing precautions or
contraindications (Table 1).

The Vaccine Information Pamphlets (required by regulation to
be used universally beginning April 15, 1992, for measles, mumps,
rubella, diphtheria, tetanus, pertussis, and poliomyelitis by all
providers administering vaccine purchased from the federal
contract) should be provided and reviewed with parents or
guardians. Private physicians who purchase their own vaccines must
use these pamphlets or must develop and use alternative vaccine
information materials that meet all legal requirements. Similar
information contained in the Important Information Statements for
other vaccines (e.g., hepatitis B and Haemophilus influenzae type
b) should be provided to all parents or guardians in public
clinics, and use of these statements should be considered by
private providers. Providers should ensure that information
materials are current and available in appropriate languages.
Providers should ask parents or guardians if they have questions
about what they have read and should ensure that they receive
satisfactory answers to their questions.

Providers should explain where and how to obtain medical care
during both day and evening hours in case of an adverse event
following vaccination.

Standard 7.

Providers follow only true contraindications.
Discussion: Accepting conditions that are not true
contraindications (Table 1) often results in the needless deferment
of indicated immunizations. The table of true contraindications is
based on the recommendations of the ACIP and the recommendations of
the Committee on Infectious Diseases (Red Book Committee) of the
AAP. These recommendations may vary from those contained in the
manufacturer's package inserts. For more detailed information,
providers should consult the published recommendations of the ACIP,
the AAP, the American Academy of Family Physicians (AAFP), and the
manufacturer's package inserts.

Standard 8.

Providers administer simultaneously all vaccine doses for
which a child is eligible at the time of each visit.

Discussion: Available evidence suggests that the simultaneous
administration of childhood vaccinations is safe and effective. In
addition, evidence suggests that the simultaneous administration of
multiple needed vaccines can potentially raise immunization
coverage by 9%-17%. If providers elect not to administer a needed
vaccine simultaneously with others (based either on their judgment
that this action will not compromise the timely immunization of the
child or on a request by the parent or guardian), they should
document such actions and the reasons why the vaccine was not
administered. The record should be flagged with an automatic recall
for an appointment so that the child can receive the needed
vaccine(s). This next appointment should be discussed with the
parent or guardian of the child.

MMR vaccine should always be used in combined form when
routine childhood vaccinations are provided.

Standard 9.

Providers use accurate and complete recording procedures.
Discussion: Providers are required by statute to record what
vaccine was administered, the date of administration (month, day,
year), the name of the manufacturer of the vaccine, the lot number,
the signature and title of the person who administered the vaccine,
and the address where the vaccine was administered. In addition,
providers should record on the child's personal immunization record
card (preferably the official state version) what vaccine was
administered, the date the vaccine was administered, and the name
of the provider. Providers should encourage parents or guardians to
maintain a copy of their child's personal immunization record card.
This card should be updated at each visit for vaccinations. If a
parent fails to bring a child's card, a new one should be issued.
It should contain all previous immunizations and should be
identified as a replacement record card. When accepting data about
previous immunizations from parents, providers should confirm that
prior doses of vaccines have actually been administered, either by
reviewing immunization record cards or by contacting former
providers and entering this verified information onto their
records. When a provider who does not routinely vaccinate or care
for a child administers a vaccine to that child, the regular
provider should be informed.

Providers with manual recordkeeping systems should maintain
separate or easily retrievable files of the immunization records of
preschool-age children to facilitate assessment of coverage as well
as the identification and recall of children who miss appointments.
In addition, immunization files of preschool-age children should be
sorted periodically, with inactive records placed into a separate
file. Providers should indicate in their records or in an
appropriately identified place all primary care services that each
child receives in order to facilitate co-scheduling with other
services.

Standard 10.

Providers co-schedule immunization appointments in conjunction
with appointments for other child health services.

Discussion: Providers of immunization-only services that
require an appointment should co-schedule immunization appointments
with other needed health-care services such as WIC, dental
examinations, or developmental screening, provided such scheduling
does not create a barrier by delaying needed immunizations.

Discussion: Providers should encourage parents or legal
guardians to inform them of adverse events following immunization.
Providers should report all such clinically important events,
including those required by law, to the Vaccine Adverse Event
Reporting System, regardless of whether they believe the events are
caused by the vaccines. Report forms and assistance are available
by calling 1-800-822-7967. Providers should document fully the
adverse event in the medical record at the time of the event or as
soon as possible thereafter.

Standard 12.

Providers operate a tracking system.
Discussion: A tracking system should generate reminders of
upcoming immunizations as well as recalls for children who are
overdue for their vaccinations. A system may be automated or manual
and may include mailed or telephone messages. In the public sector,
health department staff may also make home visits. All providers
should identify, for additional intensive tracking efforts,
children considered at high risk for failing to complete the
immunization series on schedule (e.g., children who start their
series late).

Discussion: Vaccines should be handled and stored as
recommended in the manufacturer's package inserts. The temperatures
at which vaccines are stored and transported should be monitored
daily, and the expiration date for each vaccine should be noted.

Providers using publicly purchased vaccine should periodically
report usage, wastage, loss, and inventory, as required by state or
local public health authorities.

Standard 14.

Providers conduct semi-annual audits to assess immunization
coverage levels and to review immunization records in the patient
populations they serve.

Discussion: In both the public and private sectors, the
assessment of immunization services for preschool-age patients
should include audits of immunization records or inspection of a
random sample of records a) to determine the immunization coverage
level (i.e., the percentage of 2-year-old children who are up to
date), b) to identify how frequently opportunities for simultaneous
immunization are missed, and c) to assess the quality of
documentation. The results of such assessments should be discussed
by providers as part of their ongoing quality assurance reviews and
used to develop solutions to the problems identified.

Discussion: Providers administering vaccines should maintain
a protocol which, at a minimum, discusses the appropriate vaccine
dosage, vaccine contraindications, and the recommended sites and
techniques for vaccine administration, as well as possible adverse
events and their emergency management. Such protocols should
specify the necessary emergency medical equipment, drugs (including
dosage), and personnel to safely and competently manage any medical
emergency that may arise after the administration of a vaccine. All
providers should be familiar with the content of these protocols,
their location, and how to follow them. Vaccines can be
administered in any setting (e.g., schools, churches) where
providers can adhere to these protocols.

Standard 16.

Providers practice patient-oriented and community-based
approaches.

Discussion: Public providers should routinely seek the input
of their patients on specific approaches to better serve their
immunization needs and implement the changes necessary to provide
more user-friendly services.
Public providers should adopt a community-based approach to the
provision of immunization services that recommends reaching high
coverage levels in their catchment area populations and not only in
the active patient populations they serve. Such a community-based
approach requires all public providers to publicize the
availability of their immunization services and to conduct
community outreach activities to increase demand for them. Private
providers should cooperate with local health officials in their
efforts to assure high coverage levels throughout the community.
Without high immunization coverage levels, no community is
completely protected against vaccine-preventable diseases. All
providers share responsibility for achieving the highest possible
degree of community protection.

Standard 17.

Vaccines are administered by properly trained persons.
Discussion: Only properly trained persons should administer
vaccines. However, the task of administering vaccines need not be
assigned exclusively to physicians and nurses. With appropriate
training, including the management of emergency situations, and
under professional supervision, other personnel can skillfully and
safely administer vaccines. In some jurisdictions, statutory
requirements may limit the administration of vaccines to licensed
physicians and/or nurses and may therefore create barriers to
immunization. If so, legal opinion should be sought locally to
determine the necessary steps to overcome this barrier.

Discussion: Providers include all persons who are involved in
the administration of vaccines, the management of immunization
clinics, or the support of these functions. Training and education
should cover current guidelines and recommendations of the ACIP,
AAP, and the AAFP, as well as the Standards for Pediatric
Immunization Practices and other immunization information sources,
such as the manufacturer's package inserts. Providers should also
receive information about ongoing national efforts to reach the
year 2000 goal of 90% series-complete immunization by the second
birthday.

COMMENT

These Standards are recommended for use by all health
professionals in the public and private sector who administer
vaccines to or manage immunization services for infants and
children. These Standards represent the most desirable immunization
practices that health-care providers should strive to achieve to
the extent possible. By adopting these Standards, providers can
begin to enhance and change their own policies and practices. Not
all providers will have the funds necessary to fully implement the
Standards immediately. Nevertheless, providers and programs lacking
the resources to implement the Standards fully should find them a
useful tool in better delineating immunization needs and in
obtaining additional resources to achieve the Healthy People 2000
immunization objective.

Agency Members of the Working Group for the Development of the
Standards for Pediatric Immunization Practices

Advisory Committee on Immunization Practices
American Academy of Family Physicians
American Academy of Pediatrics
American Medical Association
American Nurses Association
American Public Health Association
Association of Community Health Nursing Educators
Association of Maternal and Child Health Programs
Association of State and Territorial Directors of Nursing
Association of State and Territorial Health Officials
Centers for Disease Control and Prevention
City of Milwaukee Health Department
Council of State and Territorial Epidemiologists
Health Care Financing Administration, Medicaid Bureau
Health Resources and Services Administration, Bureau of Health Care
Delivery and Assistance, Division of Primary Care Services
Health Resources and Services Administration, Maternal Child Health
Bureau
National Association of Community Health Centers
National Association of County Health Officials
National Association of Pediatric Nurse Associates and
Practitioners
National Migrant Resource Program
National Vaccine Injury Compensation Program
United States Conference of Local Health Officers
State and Local Health Departments

Membership in the Ad Hoc Working Group does not necessarily imply
organizational endorsement.

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